TW201626957A - Thrombectomy device and system for extraction of vascular thrombi from a blood vessel - Google Patents

Thrombectomy device and system for extraction of vascular thrombi from a blood vessel Download PDF

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TW201626957A
TW201626957A TW104141880A TW104141880A TW201626957A TW 201626957 A TW201626957 A TW 201626957A TW 104141880 A TW104141880 A TW 104141880A TW 104141880 A TW104141880 A TW 104141880A TW 201626957 A TW201626957 A TW 201626957A
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funnel
removal device
thrombus removal
thrombus
catheter
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TWI741972B (en
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馬克 里布 賈科比
歐菲爾 亞雷德 哈達
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安納康德生物醫學公司
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    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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    • A61B17/12022—Occluding by internal devices, e.g. balloons or releasable wires
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    • A—HUMAN NECESSITIES
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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    • A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
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    • A61M29/00—Dilators with or without means for introducing media, e.g. remedies
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    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
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Abstract

Thrombectomy device comprising a delivery catheter (1), a dilator catheter (5) and a funnel (3), defining a distal end and a proximal end, said funnel (3) being positionable in a retracted position and in an extended position, characterized in that said funnel (3) also comprises a covering (4), the diameter of the distal end of the funnel (3) being greater in the extended position than in the retracted position.

Description

用於自血管抽取血管栓塞之血栓清除裝置及系統 Thrombosis device and system for blood vessel embolization from blood vessels

本發明係有關於能夠抽取血管栓塞之血栓清除裝置及係有關於用於自血管抽取血管栓塞之系統。 The present invention relates to a thrombus removal device capable of extracting a blood vessel plug and to a system for extracting a blood vessel plug from a blood vessel.

自1990年代以來已經於中風病例使用血管內治療。已經使用該種治療的病人數的增長緩慢但穩定。此等高度複雜的治療法廣為人使用的最大障礙乃需要有在各個層級更加協力合作的醫療體系。此等醫療網絡的主要目標係在症狀發生的6小時至8小時以內到達具有要求能力的醫療中心。 Endovascular treatment has been used in stroke cases since the 1990s. The number of patients who have used this treatment has grown slowly but is stable. The biggest obstacle to the widespread use of such highly complex treatments is the need for a medical system that works more synergistically at all levels. The primary goal of these medical networks is to reach a medical center with the required capabilities within 6 hours to 8 hours of the onset of symptoms.

晚近，第一個陽性隨機化研究已經公開(Berkhemer O.A.et al.“A randomized trial of intraarterial treatment for acute ischemic stroke.”N Engl J Med.January 2015；372：11-20.doi：10.1056/NEJMoa1411587.Epub 17 December 2014.PubMed PMID：25517348)，藉著減低了中風後三個月的失能率而驗證血栓清除術治療比較更為習知的醫藥治療的效果。此外，2015年公開四個其它主要類似的臨床研究，確切地證實了使用最新一代裝置的血栓清除術治療藉由減少損害而比較其它醫藥治療法優異。 Recently, the first positive randomization study has been published (Berkhemer OA et al. "A randomized trial of intraarterial treatment for acute ischemic stroke." N Engl J Med. January 2015; 372:11-20.doi:10.1056/NEJMoa1411587. Epub 17 December 2014. PubMed PMID: 25517348), to verify the effectiveness of more traditional medical treatments for thrombectomy by reducing the disability rate after three months of stroke. In addition, four other major clinical studies were published in 2015, confirming that thrombectomy with the latest generation of devices is superior to other medical treatments by reducing damage.

至於血管內治療，最初的策略為經由一根微導管而將血纖維蛋白溶解劑直接局部灌流至血栓內部。在2000年代早期一種 新穎裝置問市，其顯然比動脈內血纖維蛋白溶解更為有效。該裝置為螺旋狀，環繞血栓開放而輔助其抽取(MERCi®)。 As for endovascular treatment, the initial strategy is to directly perfuse the fibrinolytic agent directly into the interior of the thrombus via a microcatheter. In the early 2000s Novel devices are available, which are clearly more effective than intra-arterial fibrinolysis. The device is helical and is surrounded by a thrombus to assist in its extraction (MERCi®).

於2006年，根本上基於一根大尺寸導管導引至血栓近處以便抽吸血栓的系統變普及。導管連接到連續抽吸泵浦(Penumbra®)。此種系統經過多年的演進，尋求達成具有逐漸加大直徑的導管，能夠導航接近血栓。 In 2006, a system based on the introduction of a large-sized catheter to the vicinity of a thrombus to aspirate a thrombus was fundamentally popularized. The catheter is connected to a continuous suction pump (Penumbra®). After years of evolution, such systems have sought to reach catheters with progressively larger diameters that can navigate close to the thrombus.

所謂的支架回收器的使用始於約2009年。其使用上包含以微導管穿過血栓，然後支架前進通過微導管。一旦有護套裝置的遠端已經到達血栓的最遠端部分，支架被脫去護套，在血栓高度自行膨脹及捕獲血栓。建議等待數分鐘讓支架膨脹以增加與血栓的嚙合，及然後抽出已膨脹的支架意圖拖曳出血栓。此一最末步驟可在透過導管而抽吸時完成，試圖逆轉血流及因而提高回收血栓的機會。由於功效高，使用容易且縮短了手術時間，支架回收器已經完全替代了前述第一代裝置。 The use of the so-called stent collector began in about 2009. It is used to pass through the thrombus with a microcatheter and then the stent advances through the microcatheter. Once the distal end of the sheathing device has reached the most distal portion of the thrombus, the stent is removed from the sheath and self-expanding and capturing the thrombus at the height of the thrombus. It is recommended to wait a few minutes for the stent to expand to increase engagement with the thrombus, and then withdraw the expanded stent intent to drag the thrombus. This last step can be accomplished while pumping through the catheter, attempting to reverse the blood flow and thereby increase the chance of recovering the thrombus. The stent recycler has completely replaced the aforementioned first generation device due to its high efficacy, ease of use, and reduced operative time.

此外，當使用支架回收器時，常使用導引汽球導管。此種導管只前進到顱外頸動脈(與位在顱內動脈的血栓之距離遙遠)。當充氣位在導管末端的汽球時，導管能夠中止在汽球遠端的動脈段內的血流，此乃欲被抽取的血栓所在位置。藉著經由導管抽吸，在汽球遠端的動脈段內的血流可被逆轉以便協助血栓連同支架回收器的移除。 In addition, a guide balloon catheter is often used when using a stent collector. This catheter only advances to the extracranial carotid artery (distant from the thrombus located in the intracranial artery). When inflating a balloon at the end of the catheter, the catheter is able to stop blood flow in the arterial segment distal to the balloon, which is where the thrombus is to be extracted. By pumping through the catheter, blood flow in the arterial segment distal to the balloon can be reversed to assist in the removal of the thrombus along with the stent harvester.

要言之，目前在血栓清除裝置的使用上有兩個趨勢：一方面，所謂支架回收器(有汽球導管或無汽球導管)，及另一方面，基於抽吸導管的裝置(配合使用注射器的手動抽吸或使用抽吸泵浦的自動抽吸)。兩項技術可予組合。 In other words, there are currently two trends in the use of thrombus removal devices: on the one hand, so-called stent collectors (with or without balloon catheters), and on the other hand, devices based on suction catheters (for use) Manual suction of the syringe or automatic suction using a suction pump). Two technologies can be combined.

血栓清除裝置的一個實例描述於WO 2011082319，配合在血栓清除手術期間根據手術醫師的需要而可更換的多種梢端。在任一種情況下，本文件描述的裝置在膨脹之前須穿過血栓內部或通過血栓與動脈壁間。又復，在任一種情況下，血栓須藉天然手段或人工手段斷成碎片以便溶解。由於此等操作原理的結果，此種裝置無法讓血栓的去除能夠確保不因血凝塊碎片的釋放而造成遠端栓塞。 An example of a thrombus removal device is described in WO 2011082319, in conjunction with a variety of tips that are replaceable during the thrombectomy procedure as needed by the surgeon. In either case, the device described in this document must pass through the interior of the thrombus or through the thrombus and the wall of the artery prior to inflation. Again, in either case, the thrombus must be broken into pieces by natural means or by artificial means to dissolve. As a result of these principles of operation, such devices do not allow thrombus removal to ensure that distal embolization is not caused by the release of clot fragments.

又復，不似本發明之裝置，沒有經覆蓋的遠端，因而無法中止動脈血流，更遑論逆轉血流。 Again, unlike the device of the present invention, there is no covered distal end, so the arterial blood flow cannot be stopped, let alone reverse the blood flow.

此外，本技藝的支架回收器當部署時，在回收血栓之前需要時間(長達3分鐘)以配合適應血栓以減少血栓的破碎。當處理潛在中風時，時間乃基本關鍵要素，本裝置可用於當到達時藉抽吸而即刻回收血栓。 In addition, the stent recovery device of the present technology, when deployed, requires time (up to 3 minutes) to recover the thrombus to reduce thrombus disruption prior to recovery of the thrombus. Time is a fundamental key factor when dealing with potential strokes, and the device can be used to instantly recover a thrombus by aspiration when it arrives.

因此，依據本發明之裝置意圖用於替代抽吸裝置，改良其效果，原因在於其允許在血栓的極為近處抽吸，且使用大型口部允許閉塞動脈，中斷血流，及抽吸整個血栓而無需將血栓斷成碎片。 Thus, the device according to the invention is intended to be used in place of a suction device, improving its effectiveness, since it allows for suction in close proximity to the thrombus, and the use of a large mouth allows occlusion of the artery, interruption of blood flow, and aspiration of the entire thrombus There is no need to break the blood clot into pieces.

本發明本身即可用以截斷血流，抽吸血栓，及移除血栓；表示醫師不需要使用額外裝置來完成此等工作。 The invention itself can be used to intercept blood flow, aspirate blood clots, and remove thrombi; this means that the physician does not need to use additional equipment to perform such work.

自動化之本發明之實施例也可用於傳統環境(醫院)及非傳統環境(養老院、協助照護設施)兩者，其允許更大量部署與使用本發明，及加速血栓的移除，如此顯著地改善了病人的效果，原因在於腦部關鍵區域的血流可在更短的時間以內恢復之故。 Automated embodiments of the present invention can also be used in both traditional environments (hospitals) and non-traditional environments (nursing homes, assisted care facilities) that allow for greater deployment and use of the present invention, and accelerate the removal of thrombi, thus significantly improving The patient's effect is due to the fact that blood flow in critical areas of the brain can be recovered in less time.

本發明之裝置及系統意圖解決前述缺點，提供其它優點，容後詳述。 The apparatus and system of the present invention are intended to address the aforementioned shortcomings and provide other advantages, which are described in detail later.

依據本發明之血栓清除裝置包含一輸送導管、一錐形擴張器導管、及一漏斗，界定一遠端及一近端，該漏斗可定位在一回縮位置及一伸長位置，及其特徵在於該漏斗也包含一覆蓋物，該漏斗之遠端的直徑於伸長位置係比於回縮位置更大。 The thrombus removal device according to the present invention comprises a delivery catheter, a conical dilator catheter, and a funnel defining a distal end and a proximal end, the funnel being positionable in a retracted position and an extended position, and characterized in that The funnel also includes a cover having a distal end having a larger diameter in the extended position than the retracted position.

較佳地，該覆蓋物係從例如已膨脹的聚四氟乙烯(ePTFE)製成的不透性膜，及該覆蓋物也可包含平行於擴張器導管之長度方向的聚合物纖維。 Preferably, the covering is an impermeable membrane made of, for example, expanded polytetrafluoroethylene (ePTFE), and the covering may also comprise polymeric fibers parallel to the length of the dilator catheter.

又復，較佳地，該漏斗於回縮位置係定位在該擴張器導管的內部及於膨脹位置係定位在該擴張器導管的至少部分外部。 Still further preferably, the funnel is positioned within the retracted position within the dilator catheter and positioned in an expanded position at least a portion of the exterior of the dilator catheter.

該漏斗較佳地係由形狀記憶材料例如鎳鈦合金製成。 The funnel is preferably made of a shape memory material such as a nickel titanium alloy.

若有所需，該漏斗可在其遠端包含至少一個放射線不透性標記。 The funnel may contain at least one radiopaque marker at its distal end, if desired.

依據一較佳實施例，該覆蓋物包含光滑的親水性或斥水性被覆層。 According to a preferred embodiment, the cover comprises a smooth hydrophilic or water repellent coating.

又復，較佳地，當該漏斗的直徑膨脹時，該漏斗的長度縮短，及輸送導管、擴張器導管、及漏斗係沿相同軸定向。 Again, preferably, as the diameter of the funnel expands, the length of the funnel is shortened and the delivery catheter, dilator catheter, and funnel are oriented along the same axis.

依據本發明之裝置也可包括重新護套元件，諸如套管，用於將漏斗重新導入輸送導管內部。 The device according to the invention may also comprise a re-sheathing element, such as a cannula, for reintroducing the funnel into the interior of the delivery catheter.

該漏斗膨脹至血管直徑以便允許閉塞血流，及甚至當經由裝置抽吸時逆轉血流，如此以極短的拖曳距離協助血栓的抽取，且有能力將整個血栓捕獲在其內部而不會斷成碎片。 The funnel expands to the diameter of the blood vessel to allow occlusion of the blood flow, and even reverses blood flow when pumped through the device, thus assisting in the extraction of the thrombus with a very short drag distance and the ability to capture the entire thrombus inside without breaking Fragmented.

本發明也關於一種用於自血管抽取血管栓塞之系 統，其包含如前述之一血栓清除裝置、一通訊通道、一控制模組、一資料儲存裝置、及一導引系統。 The invention also relates to a system for extracting blood vessel embolization from a blood vessel The system includes a thrombus removal device, a communication channel, a control module, a data storage device, and a guidance system.

該系統也包含一成像裝置、一第一放射線標記、及一第二放射線標記，其中該第一放射線標記指示漏斗的遠端之位置，及該第二放射線標記指示血管栓塞之位置，及一電腦輔助控制器。 The system also includes an imaging device, a first radiation mark, and a second radiation mark, wherein the first radiation mark indicates a position of a distal end of the funnel, and the second radiation mark indicates a position of the blood vessel plug, and a computer Auxiliary controller.

1‧‧‧輸送導管 1‧‧‧ delivery catheter

2‧‧‧抽吸漏斗導管、抽吸漏斗 2‧‧‧Aspirating funnel catheter, suction funnel

3‧‧‧經覆蓋之支架、經覆蓋之漏斗、支架漏斗、自膨式漏斗 3‧‧‧ Covered stent, covered funnel, stent funnel, self-expanding funnel

4‧‧‧漏斗覆蓋物 4‧‧‧Fountain Cover

5‧‧‧錐形擴張器導管 5‧‧‧Conical dilator catheter

6‧‧‧血管、動脈 6‧‧‧Vascular, arterial

7‧‧‧血栓 7‧‧‧thrombotic

8‧‧‧光滑被覆層 8‧‧‧Smooth coating

9‧‧‧導管梢端 9‧‧‧ catheter tip

10‧‧‧導管梢端 10‧‧‧ catheter tip

11‧‧‧套管 11‧‧‧ casing

12‧‧‧放射線不透性標記、放射線攝影標記 12‧‧‧radiation impermeable markers, radiographic markers

13‧‧‧放射線不透性標記、放射線攝影標記 13‧‧‧radiation impermeable markers, radiographic markers

20‧‧‧成像裝置 20‧‧‧ imaging device

22‧‧‧通訊通道 22‧‧‧Communication channel

24‧‧‧控制模組 24‧‧‧Control Module

26‧‧‧資料儲存裝置 26‧‧‧Data storage device

28‧‧‧電腦輔助控制器 28‧‧‧Computer Aided Controller

30‧‧‧自動化近端裝置 30‧‧‧Automatic proximal device

為求更明白瞭解前文說明，附上數幅圖式，其示意地及僅係藉由非限制性實例表示該實施例之實際案例。 For a better understanding of the foregoing description, several figures are attached, which are illustrative and merely representative of the actual examples of the embodiments by way of non-limiting example.

圖1為依據本發明之血栓清除裝置呈其接近組態之示意平面圖，其係用於清除通過血管的通路及到達血栓所在的動脈。 BRIEF DESCRIPTION OF THE DRAWINGS Figure 1 is a schematic plan view of a thrombectomy device in accordance with the present invention in a proximal configuration for clearing passage through a blood vessel and reaching an artery where the thrombus is located.

圖2為依據本發明之血栓清除裝置呈其回縮或導航組態之示意平面圖，用以導航輸送導管(在其內部攜帶抽吸漏斗導管)至血栓表面。 2 is a schematic plan view of a thrombectomy device in accordance with the present invention in its retracted or navigation configuration for navigating a delivery catheter (with a suction funnel catheter inside) to the surface of the thrombus.

圖3為依據本發明之血栓清除裝置呈其對齊或準備膨脹組態之示意平面圖，準備輸送該抽吸漏斗。 Figure 3 is a schematic plan view of a thrombectomy device in accordance with the present invention in a configuration in which it is aligned or ready for expansion, ready to deliver the aspiration funnel.

圖4為在其抽吸之前漏斗調整適應本身至血管形狀以面對血栓，依據本發明之血栓清除裝置呈其已膨脹或準備抽吸組態之示意平面圖。 Figure 4 is a schematic plan view of the thrombus removal device according to the present invention in its expanded or ready-to-suck configuration prior to its aspiration adjustment adapted to itself to the vessel shape to face the thrombus.

圖5為依據本發明之血栓清除裝置之示意平面圖，描繪呈其部署組態的整個裝置，包括全部裝置組件及描繪具有親水性被覆層之點。 Figure 5 is a schematic plan view of a thrombectomy device in accordance with the present invention depicting the entire device in its deployed configuration, including all device components and depicting points having a hydrophilic coating.

圖6為依據本發明之血栓清除裝置之示意平面圖，描繪呈其已膨脹組態的整個裝置，包括全部裝置組件及描繪具有親水性被覆層之點。 Figure 6 is a schematic plan view of a thrombectomy device in accordance with the present invention depicting the entire device in its expanded configuration, including all device components and depicting points having a hydrophilic coating.

圖7A、7B及7C表示依據本發明之血栓清除裝置之示意平面圖，描繪其中該裝置係呈數個不同位置。 Figures 7A, 7B and 7C show schematic plan views of a thrombus removal device in accordance with the present invention, depicting the device in a number of different positions.

圖8為略圖描繪依據本發明之自動化血栓清除裝置。 Figure 8 is a schematic depiction of an automated thrombus removal device in accordance with the present invention.

依據本發明之血栓清除裝置特別適合用於自顱內動脈去除血栓而不會造成或使得血栓斷成碎片，且不會對顱內動脈造成損傷，如此避免了額外血栓的發展。雖然該裝置係特別適用於去除顱內動脈血栓，但也可用於去除任何動脈或靜脈內的血栓。 The thrombus removal device according to the present invention is particularly suitable for removing thrombus from the intracranial artery without causing or causing the thrombus to break into pieces without causing damage to the intracranial artery, thus avoiding the development of additional thrombus. Although the device is particularly suitable for the removal of intracranial arterial thrombosis, it can also be used to remove any arterial or venous thrombosis.

依據本發明之血栓清除裝置包含一個錐形擴張器導管5、一個抽吸漏斗導管2(包含一個經覆蓋之支架3及一個推桿元件，及於一較佳實施例中，包含一個海波管(hypotube)主軸)及一根輸送導管1，各自具有遠端及近端的界定。此種裝置具有四種不同的組配狀態：1)接近組態，錐形擴張器導管5遠在該裝置的其它元件前方，導航通過血管而到達欲被去除的血栓7，如圖1中描繪；2)回縮組態或導航組態，抽吸漏斗2在輸送導管1內部回縮(未經膨脹)且在距輸送導管1遠端的某個距離的近端固定，於此種組態中，裝置顯現了到達血栓7提升的導航能力及增強的推進能力，如圖2中描繪；3)對齊組態或準備膨脹組態，經覆蓋之漏斗3的遠端與輸送導管1的遠端對齊且與血栓7接觸，如圖3中描繪；4)已膨脹組態或準備抽吸組態，經覆蓋之漏斗3膨脹至血管6的直徑且與血栓7緊密接觸，輸送導管1近端固定在距漏斗3之遠端的某個距離及移除錐形擴張器導管5，於此種組態中，漏斗3遠端的直徑係大於先前組態的直徑而當抽吸時方便配置血栓7，如圖4中描繪。 The thrombus removal device according to the present invention comprises a conical dilator catheter 5, a suction funnel catheter 2 (including a covered stent 3 and a pusher member, and in a preferred embodiment, a hypotube) (hypotube) spindle and a delivery catheter 1, each having a distal end and a proximal end. This device has four different combinations: 1) Proximity configuration, the conical dilator catheter 5 is far in front of the other components of the device, navigates through the blood vessel to reach the thrombus 7 to be removed, as depicted in Figure 1. 2) Retraction configuration or navigation configuration, the suction funnel 2 is retracted inside the delivery catheter 1 (unexpanded) and fixed at a proximal end of the distance from the distal end of the delivery catheter 1, in this configuration In the device, the device shows the navigation ability and enhanced propulsion ability to reach the thrombus 7 as shown in Figure 2; 3) Align the configuration or prepare the expansion configuration, the distal end of the covered funnel 3 and the distal end of the delivery catheter 1 Aligned and in contact with the thrombus 7, as depicted in Figure 3; 4) Expanded configuration or ready for aspiration configuration, the covered funnel 3 expands to the diameter of the vessel 6 and is in intimate contact with the thrombus 7, the delivery catheter 1 is proximally fixed At a certain distance from the distal end of the funnel 3 and removal of the conical dilator catheter 5, in this configuration, the diameter of the distal end of the funnel 3 is greater than the previously configured diameter and facilitates the placement of the thrombus when inhaled 7 , as depicted in Figure 4.

優異地，漏斗3於回縮組態或導航組態中及於對齊組 態或準備膨脹組態中係位在輸送導管1內部，而於已膨脹組態或準備抽吸組態中係位在輸送導管1的至少部分外部。 Excellently, the funnel 3 is in the retraction configuration or navigation configuration and in the alignment group The state or ready to expand configuration is centered within the delivery catheter 1 and is tied outside of at least a portion of the delivery catheter 1 in an expanded configuration or ready for aspiration configuration.

依據較佳實施例，漏斗3為覆蓋有不透性膜的支架。此種支架具有可變的直徑，在血栓7近端的一點能夠膨大至血管6的直徑，如此能夠中止血管的血流及捕獲在血管內部的整個血栓7，而無需將血栓斷成碎片。支架較佳地為自膨式，但也可藉其它機制膨脹之，諸如在支架內部的充氣汽球。 According to a preferred embodiment, the funnel 3 is a stent covered with an impermeable membrane. Such a stent has a variable diameter and is expandable to the diameter of the blood vessel 6 at a point near the proximal end of the thrombus 7, so that blood flow to the blood vessel and the entire thrombus 7 inside the blood vessel can be stopped without breaking the thrombus into pieces. The stent is preferably self-expanding, but may be inflated by other mechanisms, such as an inflatable balloon inside the stent.

漏斗3骨架較佳地係由形狀記憶材料製成：金屬類(包括金屬合金類)、聚合物類、陶瓷類、或具有合宜機械性質的其任一項組合。依據一較佳實施例，該骨架係為鎳鈦合金(NitinolTM)(50%鎳/50%鈦合金，NiTi)製成的支架。此種骨架可在其遠端及其它戰略點包括放射線不透性標記13，其允許醫師在使用螢光鏡檢時知曉該裝置的精確位置。 The funnel 3 skeleton is preferably made of a shape memory material: a metal (including metal alloys), a polymer, a ceramic, or any combination thereof having suitable mechanical properties. A stent according to the preferred embodiment, the skeletal system is a nickel-titanium alloys (Nitinol TM) (50% Ni / 50% titanium, of NiTi) made. Such a skeleton may include a radiopaque marker 13 at its distal end and other strategic points that allows the physician to know the precise location of the device when using a fluoroscopy.

漏斗3可具有覆蓋物，該漏斗覆蓋物4為一種可生物相容性材料或多於一種可生物相容性材料的組合製成的不透性膜。依據一較佳實施例，漏斗覆蓋物4為可生物相容性聚合物、彈性體材料、或其它合宜塑性材料。於一個較佳實施例中，該種聚合物為具有彈性體性質的耐用可生物相容性聚胺基甲酸酯，其允許當需要時漏斗3重新護套。於另一個較佳實施例中，漏斗覆蓋物4為已膨脹的聚四氟乙烯(ePTFE)，聚合物纖維係平行於導管1之長度方向定向，如此，對膨脹的阻力減低或幾乎沒有阻力，及未施加外力時漏斗回彈減低或幾乎沒有回彈。 The funnel 3 can have a cover that is an impermeable membrane made of a biocompatible material or a combination of more than one biocompatible material. According to a preferred embodiment, the funnel cover 4 is a biocompatible polymer, an elastomeric material, or other suitable plastic material. In a preferred embodiment, the polymer is a durable, biocompatible polyurethane having elastomeric properties that allows the funnel 3 to be resheathed when needed. In another preferred embodiment, the funnel cover 4 is expanded polytetrafluoroethylene (ePTFE), the polymer fibers being oriented parallel to the length of the conduit 1, such that the resistance to expansion is reduced or has little resistance. When the external force is not applied, the funnel rebounds less or hardly rebounds.

依據本發明之裝置的可膨脹式經覆蓋的遠端使得動脈血流中止，當加上減壓時，血流甚至逆轉。因而可能抽吸整個血 栓7，及因而減少且甚至防止於手術期間或於裝置抽回期間血栓斷片的脫落。 The expandable covered distal end of the device according to the invention causes arterial blood flow to be discontinued, and when decompression is applied, the blood flow is even reversed. So it is possible to pump the whole blood The plug 7, and thus reduces and even prevents the shedding of the thrombus during surgery or during withdrawal of the device.

取決於個別血栓清除裝置的特殊規格，本發明描述之裝置的漏斗3可在血栓7移除之前、之中及之後，在輸送導管1內部重新護套。換言之，裝置許可在手術期間的任何時間進行漏斗3的重新護套，即便當血栓7正在被抽取期間亦復如此。 Depending on the particular specifications of the individual thrombectomy device, the funnel 3 of the device described herein can be resheath inside the delivery catheter 1 before, during and after removal of the thrombus 7. In other words, the device permits re-sheathing of the funnel 3 at any time during the procedure, even when the thrombus 7 is being drawn.

本發明之裝置的另一項相關特色為該裝置未曾意圖穿越或壓縮血栓7。因此，具有確保移除完整血栓7的優點，如此避免了可能的遠端栓塞。 Another related feature of the device of the present invention is that the device has not been intended to traverse or compress the thrombus 7. Thus, there is the advantage of ensuring the removal of intact thrombus 7, thus avoiding possible distal embolization.

又復，漏斗3意欲且能夠調整其形狀及其長度適應周圍血管6，因而以載有血栓7的裝置移出期間遭逢狹窄通道為例，漏斗3的形狀改變包圍住血栓7上的任何尺寸改變，避免了血栓物質有任何滲漏。當通過狹窄通道時，隨著漏斗3的縮窄，漏斗3也成比例地變延長，使得整個血栓7保持安全地在漏斗3內部。 Again, the funnel 3 is intended and capable of adjusting its shape and length to accommodate the surrounding blood vessels 6, thus exemplifying that the shape of the funnel 3 surrounds any size change on the thrombus 7 as a result of the narrow passage during the removal of the device carrying the thrombus 7 Avoid any leakage of thrombus material. As it passes through the narrow passage, as the funnel 3 narrows, the funnel 3 also prolongs proportionally, so that the entire thrombus 7 remains safely inside the funnel 3.

圖5顯示依據本發明之血栓清除裝置，該裝置包含錐形擴張器導管5、抽吸漏斗3、及輸送導管1。 Figure 5 shows a thrombus removal device according to the invention comprising a conical dilator catheter 5, a suction funnel 3, and a delivery catheter 1.

為了輔助說明，裝置的末端被界定為遠端及近端，遠端最遠離操控依據本發明之裝置的使用者及因而最靠近欲被去除的血栓7，而近端係最接近使用者的該端及因而最遠離血栓7。 To aid in illustration, the distal end of the device is defined as the distal end and the proximal end, the distal end being furthest away from the user operating the device according to the invention and thus closest to the thrombus 7 to be removed, and the proximal end is closest to the user. The end and thus the farthest away from the blood clot 7.

依據本發明之血栓清除裝置可呈四種不同組態：接近組態(顯示於圖1)；回縮或導航組態(顯示於圖2)；對齊或準備膨脹組態(顯示於圖3)；已膨脹或準備抽吸組態(顯示於圖4)，容後詳述，於已膨脹組態中，漏斗3遠端的直徑係大於任何其它組態的直徑。 The thrombectomy device according to the invention can be configured in four different configurations: proximity configuration (shown in Figure 1); retraction or navigation configuration (shown in Figure 2); alignment or preparation of the expansion configuration (shown in Figure 3) The expansion or preparation of the suction configuration (shown in Figure 4), as detailed later, in the expanded configuration, the diameter of the distal end of the funnel 3 is greater than any other configured diameter.

於回縮組態及對齊組態中，漏斗3係位在輸送導管1 內部；而於已膨脹組態中，漏斗3係位在輸送導管1的至少部分外部。 In the retraction configuration and alignment configuration, the funnel 3 is in the delivery catheter 1 Internal; in the expanded configuration, the funnel 3 is positioned outside of at least a portion of the delivery catheter 1.

依據一較佳實施例，漏斗3為具有不透性膜覆蓋物的支架。 According to a preferred embodiment, the funnel 3 is a stent having an impermeable membrane cover.

支架漏斗3較佳地為自膨式，但也可藉其它機制膨大，諸如在其內部的充氣汽球。 The stent funnel 3 is preferably self-expanding, but may be inflated by other mechanisms, such as an inflatable balloon inside it.

漏斗3較佳地係由具有形狀記憶性質的任何材料製成，包括金屬類(甚至金屬合金類)、聚合物類、陶瓷類、或具有合宜機械性質的組合，且漏斗3可在其遠端及其它戰略點具有放射線不透性標記13。依據一較佳實施例，漏斗3係由鎳鈦合金(NitinolTM)製成。如此，漏斗3的遠端在脫護套時膨脹，原因在於漏斗具有形狀記憶且為自膨式，及當漏斗3在體溫而退出輸送導管1時其自然傾向於膨脹。但須注意此種膨脹可藉其它系統執行，例如藉充氣而在漏斗內部具有所需直徑的汽球執行。 The funnel 3 is preferably made of any material having shape memory properties, including metals (even metal alloys), polymers, ceramics, or combinations having suitable mechanical properties, and the funnel 3 can be at its distal end. And other strategic points have radiopaque markers 13 . According to a preferred embodiment, the hopper 3 are made of a nickel-titanium alloy (Nitinol TM). As such, the distal end of the funnel 3 expands during de-sheathing because the funnel has a shape memory and is self-expanding, and naturally tends to expand as the funnel 3 exits the delivery catheter 1 at body temperature. It should be noted, however, that such expansion can be performed by other systems, such as by a balloon having a desired diameter inside the funnel by inflation.

又復，漏斗覆蓋物4為一種可生物相容性材料或多於一種可生物相容性材料的組合製成的不透性膜。依據一較佳實施例，漏斗覆蓋物4為可生物相容性聚合物、彈性體材料、或其它合宜塑性材料。於一個較佳實施例中，該種聚合物為具有彈性體性質的耐用可生物相容性聚胺基甲酸酯，其允許當需要時漏斗3重新護套。於另一個較佳實施例中，漏斗覆蓋物4為已膨脹的聚四氟乙烯(ePTFE)，ePTFE聚合物纖維係平行於導管1之長度方向定向，如此，對膨脹的阻力減低或幾乎沒有阻力，及未施加外力時漏斗3回彈減低或幾乎沒有回彈。 Again, the funnel cover 4 is an impermeable membrane made of a biocompatible material or a combination of more than one biocompatible material. According to a preferred embodiment, the funnel cover 4 is a biocompatible polymer, an elastomeric material, or other suitable plastic material. In a preferred embodiment, the polymer is a durable, biocompatible polyurethane having elastomeric properties that allows the funnel 3 to be resheathed when needed. In another preferred embodiment, the funnel cover 4 is expanded polytetrafluoroethylene (ePTFE), and the ePTFE polymer fibers are oriented parallel to the length of the conduit 1, such that the resistance to expansion is reduced or has little resistance. , and the funnel 3 rebounds less or hardly rebounds when no external force is applied.

於本發明之一較佳實施例中，覆蓋物4可具有光滑被覆層8(親水性或斥水性)，且每個裝置組件的戰略點，例如導管梢 端9、10(顯示於圖5)也可具有光滑被覆層8。 In a preferred embodiment of the invention, the cover 4 may have a smooth coating 8 (hydrophilic or water repellent) and strategic points of each device component, such as a catheter tip The ends 9, 10 (shown in Figure 5) may also have a smooth coating layer 8.

再度參考圖4，於本發明之一個較佳實施例中，遠端漏斗3為自膨式。於本發明之其它實施例中，漏斗3的膨脹可透過各種機械手段包括使用汽球達成。優異地，漏斗3的膨脹將閉塞了近端血流，藉抽吸而逆轉遠端動脈段的血流，極短的血栓拖曳距離，及有能力捕獲整個血栓7在漏斗內部不會斷成碎片而有助於血栓的抽取。 Referring again to Figure 4, in a preferred embodiment of the invention, the distal funnel 3 is self-expanding. In other embodiments of the invention, the expansion of the funnel 3 can be achieved by various mechanical means including the use of a balloon. Excellently, the expansion of the funnel 3 will occlude the proximal blood flow, reversing the blood flow of the distal arterial segment by aspiration, a very short thrombus towing distance, and the ability to capture the entire thrombus 7 without breaking into pieces inside the funnel. It helps in the extraction of blood clots.

如於圖3及圖4中描繪，具有自膨式支架的漏斗3的另一項特色為當漏斗3膨大至血管6的直徑時，漏斗3縮短。此種漏斗3長度的減少係與動脈直徑成反比，換言之：在5毫米直徑的動脈內，漏斗3的長度係比在2毫米直徑的動脈內更短。甚至更優異地，由於自膨式漏斗3與其框架間的可生物相容性不透性膜的精確組合故，具有自膨式支架的漏斗3將負荷於動脈壁上的徑向力分攤遍布其全長。藉此方式，能夠確保具有約2毫米至約6毫米(兩者皆含)間之直徑的全部動脈施加於動脈壁上的總壓力維持恆定。 As depicted in Figures 3 and 4, another feature of the funnel 3 with self-expanding stent is that the funnel 3 is shortened as the funnel 3 expands to the diameter of the blood vessel 6. The reduction in the length of such a funnel 3 is inversely proportional to the diameter of the artery, in other words: in a 5 mm diameter artery, the length of the funnel 3 is shorter than in a 2 mm diameter artery. Even more excellent, due to the precise combination of the biocompatible, impermeable membrane between the self-expanding funnel 3 and its frame, the funnel 3 with the self-expanding stent distributes the radial forces that are loaded on the arterial wall throughout it. full length. In this way, it is ensured that the total pressure exerted on the arterial wall by all arteries having a diameter between about 2 mm and about 6 mm (both inclusive) is maintained constant.

本發明之裝置具有優異的抽吸力，且由於裝置的多樣化抽吸漏斗故，使其能夠抽取多種大小、形狀及尺寸的血栓。實際上，漏斗的預見組態係意圖調整至血管壁及其幾何形狀，且配合血管直徑(高達5.9毫米，0.232吋)：裝置的此種特定特色使其比較其它市售裝置(例如，Navien 0.064吋，Penumbra 0.072吋)可能抽吸更大的血栓且具有更高的真空吸力。於本發明之較佳實施例中，抽吸漏斗導管2係由覆蓋有薄膜的支架及海波管組成，在抽吸血栓7時，海波管(在近端有適當的連接器)允許操控漏斗3，及於裝置抽出過程中，縮短進行整個血栓清除裝置手術介入需要的時間。 The device of the present invention has excellent suction power and is capable of extracting thrombus of various sizes, shapes and sizes due to the diverse suction funnel of the device. In fact, the predictive configuration of the funnel is intended to be adjusted to the vessel wall and its geometry, and to match the vessel diameter (up to 5.9 mm, 0.232 吋): this particular feature of the device makes it comparable to other commercially available devices (eg, Navien 0.064) Hey, Penumbra 0.072吋) may pump a larger thrombus and have a higher vacuum suction. In a preferred embodiment of the invention, the suction funnel catheter 2 is comprised of a stent covered with a membrane and a hypotube. When the thrombus is aspirated, the hypotube (with appropriate connectors at the proximal end) allows manipulation The funnel 3, and during the device extraction process, shortens the time required to perform the surgical intervention of the entire thrombectomy device.

血栓清除裝置較佳地是中等尺規，例如6F(2毫米(mm))，但非限制根據與血管6的類型及直徑相關的裝置尺寸具有不同需要的其它尺寸。顯然裝置可具有不同的呈現型態以當改變自膨式漏斗3所能達到的最大直徑時滿足此等不同的需求。總而言之，一旦移動到輸送導管1外部時，漏斗3的遠端將膨大至動脈6在該點的直徑。 The thrombus ablation device is preferably a medium ruler, such as 6F (2 millimeters (mm)), but is not limited to other sizes that are different depending on the size of the device associated with the type and diameter of the blood vessel 6. It will be apparent that the device can have different presentation patterns to meet these different needs when changing the maximum diameter that the self-expanding funnel 3 can achieve. In summary, once moved to the outside of the delivery catheter 1, the distal end of the funnel 3 will expand to the diameter of the artery 6 at that point.

如圖5中描繪，較佳地讓錐形擴張器導管5、抽吸漏斗導管2、及輸送導管1沿相同軸定向。此種分布狀況減少了漏斗3及抽吸漏斗導管2與輸送導管1的組合上方的橫過軸向力。尤有甚之，此種分布狀況允許全部裝置組件的同時操控。 As depicted in Figure 5, the conical dilator catheter 5, the aspiration funnel catheter 2, and the delivery catheter 1 are preferably oriented along the same axis. This distribution reduces the cross-axial force above the combination of the funnel 3 and the suction funnel conduit 2 and the delivery conduit 1. In particular, this distribution allows simultaneous manipulation of all device components.

裝置的定位與操作係藉螢光鏡檢輔助，因此，裝置包括有些放射線不透性標記。 The positioning and operation of the device is assisted by a fluorescent microscope, and therefore, the device includes some radiopaque markers.

參考圖6，為了抽吸血栓7，經由抽吸漏斗導管2及輸送導管3：其中之一者或兩者而施加減壓。抽吸係使用抽吸裝置施加，抽吸裝置可以是在導管近端的注射筒或抽吸泵浦。一旦施加減壓之後，血流被逆轉，而血栓7被抽吸入裝置內部。 Referring to Figure 6, in order to aspirate the thrombus 7, a reduced pressure is applied via one or both of the aspiration funnel catheter 2 and the delivery catheter 3. The suction system is applied using a suction device, which may be a syringe or suction pump at the proximal end of the catheter. Once the decompression is applied, the blood flow is reversed and the thrombus 7 is drawn into the interior of the device.

為了避免血栓7物質的任何滲漏，除了沿裝置方向施加的減壓之外，抽吸漏斗2內部可具有任何物理元件、化學元件、生物化學元件、機械元件、或其組合，其能夠在手術程序期間在任一種情況下保有血栓7。於一個較佳實施例中，該保持系統可由尖銳物理元件製成，諸如棘刺、扦插、鋸齒、夾具或其任一項組合。 In order to avoid any leakage of the thrombus substance 7, in addition to the reduced pressure applied in the direction of the device, the interior of the suction funnel 2 may have any physical element, chemical element, biochemical element, mechanical element, or a combination thereof, which is capable of surgery Thrombosis is maintained in either case during the procedure. In a preferred embodiment, the retention system can be made of sharp physical elements such as spines, cuttings, serrations, clamps, or any combination thereof.

到這一點，全部剩下的只有抽出裝置連同血栓7，維持裝置內部的減壓。此點為可能的原因在於隨著裝置的前進深入(例如，自顱動脈到主動脈)，動脈系統的直徑增加，但於遭遇狹窄 通道之情況下，漏斗3係經設計以涵蓋血栓7上的任何尺寸變化，避免血栓7物質的任何滲漏。當通過狹窄通道時，當漏斗3成比例地縮窄時漏斗也變長，允許整個血栓7能夠安全地維持在漏斗3內部。 At this point, all that remains is the extraction device along with the thrombus 7, which maintains the decompression inside the device. The reason for this is that as the device progresses deeper (for example, from the cranial artery to the aorta), the diameter of the arterial system increases, but the stenosis is encountered. In the case of a channel, the funnel 3 is designed to cover any dimensional changes on the thrombus 7 to avoid any leakage of the thrombus 7 material. When passing through the narrow passage, the funnel also becomes longer as the funnel 3 is proportionally narrowed, allowing the entire thrombus 7 to be safely maintained inside the funnel 3.

當抽吸漏斗導管2藉其近端自輸送導管1拔出時，在進一步使用之前，選擇性的重新護套元件可允許使用者將漏斗3重新導入輸送導管1內部。此種重新護套元件可以是附接至輸送導管1的任何特定固定件，或可以是獨立元件，其可以是剛性或塑性。於一個較佳實施例中，此種元件乃輸送導管1的止血閥之修改，具有適當錐形閉合件，用於將抽吸漏斗2閉合至止血閥的直徑。於另一個較佳實施例中，重新護套元件可以是具有適當錐形閉合件及直徑的套管11或漏斗，其可以是剛性或塑性；若此種元件具有塑性表現，則可調整至止血閥的直徑，及甚至***其入口內用以協助重新護套。 When the suction funnel catheter 2 is withdrawn from the delivery catheter 1 by its proximal end, the optional re-sheathing element may allow the user to reintroduce the funnel 3 into the interior of the delivery catheter 1 prior to further use. Such a re-sheathing element may be any particular fastener attached to the delivery catheter 1, or may be a separate element, which may be rigid or plastic. In a preferred embodiment, such an element is a modification of the hemostatic valve of the delivery catheter 1 with a suitable conical closure for closing the suction funnel 2 to the diameter of the hemostatic valve. In another preferred embodiment, the re-sheathing element can be a cannula 11 or a funnel having a suitable conical closure and diameter, which can be rigid or plastic; if such element has plastic behavior, it can be adjusted to stop bleeding The diameter of the valve, and even its inlet, is used to assist in re-sheathing.

圖8描繪本發明之血栓清除裝置，其允許自動化操縱血栓清除裝置通過血管系統。系統包含放射線攝影標記12指示在動脈6中的血栓7位置，及放射線攝影標記13指示血栓清除裝置在血管系統內之位置，成像裝置20其檢測放射線攝影標記，通訊通道22提供用於傳送影像到控制模組24的手段，控制模組24經規劃用以許可導引血栓清除裝置的部署及資料之儲存於資料儲存裝置26上，其乃控制模組與血栓清除裝置間通訊的構件，及自動化近端裝置30其提供導引系統以部署血栓清除裝置。控制模組可以是可規劃邏輯控制器、電腦等。於一個較佳實施例中，控制模組24係由電腦輔助控制器28導引。通訊通道22可以是乙太網路、WIFI、藍牙等。控制模組24係經規劃以指導操作血栓清除裝置的醫師或技術員，允許血栓清 除裝置用在非醫院設施裡，諸如養老院或協助照護設施。藉由允許血栓清除裝置被用在「現場」，進行血栓清除術所需時間大為縮短，顯著改善了病人的效果。 Figure 8 depicts a thrombectomy device of the present invention that allows automated manipulation of a thrombectomy device through a vascular system. The system includes a radiographic marker 12 indicating the location of the thrombus 7 in the artery 6, and a radiographic marker 13 indicating the location of the thrombus removal device within the vascular system, the imaging device 20 detecting the radiographic marker, and the communication channel 22 providing for transmitting images to The means for controlling the module 24, the control module 24 is planned to permit the deployment of the guided thrombus removal device and the storage of the data on the data storage device 26, which is a component for communication between the control module and the thrombus removal device, and automation The proximal device 30 provides a guidance system to deploy a thrombus removal device. The control module can be a programmable logic controller, a computer, or the like. In a preferred embodiment, control module 24 is directed by computer assisted controller 28. The communication channel 22 can be Ethernet, WIFI, Bluetooth, and the like. The control module 24 is planned to guide the physician or technician operating the thrombectomy device to allow thrombus clearing The device is used in non-hospital facilities such as nursing homes or assisted care facilities. By allowing the thrombus removal device to be used "on site," the time required for thrombectomy is greatly reduced, significantly improving patient outcomes.

控制也可透過控制器執行，諸如用於其它現行醫療裝置的控制器。於另一個較佳實施例中，系統可透過手動控制。 Control can also be performed by a controller, such as a controller for other current medical devices. In another preferred embodiment, the system is controllable by hand.

如熟諳技藝人士顯然易知，本發明之裝置乃不同導管的組合設計，用以組合作為一個較佳序列動作中的獨特裝置。但其組件或特定子集可用於較佳序列以外的不同序列，及甚至與其它裝置分開使用或組合使用。 As is apparent to those skilled in the art, the device of the present invention is a combination of different conduits designed to be combined as a unique device in a preferred sequence of motions. However, its components or specific subsets can be used for different sequences than the preferred sequences, and even used separately or in combination with other devices.

舉例言之，在使用本發明描述之裝置以外的其它裝置之前，錐形擴張器導管可用於清除經由血管至任何病灶的通道。同理，輸送導管與抽吸漏斗導管的子集可組合已知用作為支架回收器的該種血栓清除裝置，用於安全地固定血栓以避免血栓物質的任何滲漏。 For example, a tapered dilator catheter can be used to clear a passageway through a blood vessel to any lesion prior to use of a device other than the device described herein. Similarly, a subset of delivery catheters and aspiration funnel catheters can be combined with such a thrombus removal device known to be used as a stent retriever for securely securing a thrombus to avoid any leakage of thrombotic material.

裝置製造 Device manufacturing

本發明之個別成分可使用熟諳技藝人士眾所周知之技術組裝。用於本發明之裝置的材料乃熟諳技藝人士常用的材料。裝置的特定部件之被覆物及覆蓋物也是常用者且以熟諳技藝人士眾所周知之技術施用。 The individual ingredients of the present invention can be assembled using techniques well known to those skilled in the art. The materials used in the device of the present invention are materials commonly used by those skilled in the art. The coverings and coverings of the particular components of the device are also commonly used and are applied by techniques well known to those skilled in the art.

使用方法 Instructions

使用血栓清除裝置以抽取血管栓塞之方法包含下列步驟：將血栓清除裝置導入血管內部，透過擴張器導管而將血栓清除裝置導引至血栓的近處距離，將導引導管定位相鄰於血栓，部署漏斗，抽吸血栓，包圍血栓至漏斗內部同時維持血栓物質的完好， 及自血管移除血栓清除裝置及血栓。 The method of using a thrombus removal device to extract a blood vessel embolization comprises the steps of: introducing a thrombus removal device into the interior of the blood vessel, guiding the thrombus removal device to a proximal distance of the thrombus through the dilator catheter, positioning the guiding catheter adjacent to the thrombus, Deploy the funnel, aspirate the thrombus, surround the thrombus to the inside of the funnel while maintaining the integrity of the thrombus material, And remove the thrombus removal device and thrombus from the blood vessel.

雖然只顯示及描述本發明之某些特色及實施例，但熟諳技藝人士顯然易知實質上未背離申請專利範圍各項中引述的主旨之新穎教示及優點可做出許多修改及變化(例如，各種元件的大小、尺寸、結構、形狀及比例的變化、參數值(例如，溫度、壓力等)、安裝配置、材料的使用、顏色、方向性等)。任何處理程序或方法步驟之順序或序列依據替代實施例可予改變或重新排序。因此須瞭解隨附之申請專利範圍意圖涵蓋落入本發明之精髓範圍內的全部此等修改及變化。又復，試圖提供具體實施例之精簡描述，並未描述實際執行上的全部特色(亦即，與預期進行本發明之目前最佳模式無關者，或與致能本案所請發明無關者)。須瞭解於任何此種實際執行之發展中，如同於任何工程計畫或設計計畫中，可做無數特定實作決策。此種發展的努力複雜且耗時，但雖言如此已從本文揭示獲益之熟諳技藝人士無需透過不必要的實驗即可進行例行性設計、製作、及製造。 While only certain features and embodiments of the invention are shown and described, it is apparent to those skilled in the <RTIgt; Changes in the size, size, structure, shape, and proportion of various components, parameter values (eg, temperature, pressure, etc.), mounting configuration, use of materials, color, directionality, etc.). The order or sequence of any process or method steps may be changed or re-sequenced according to alternative embodiments. It is therefore to be understood that the appended claims are intended to cover all such modifications and Further, an attempt is made to provide a concise description of the specific embodiments and does not describe all of the features of the actual implementation (i.e., unrelated to the presently preferred mode for carrying out the invention, or the ones that are not related to the inventions claimed herein). It is important to understand that in any such actual implementation development, as in any engineering project or design project, countless specific implementation decisions can be made. Such development efforts are complex and time consuming, although skilled artisans who have benefited from the disclosure herein can routinely design, fabricate, and manufacture without unnecessary experimentation.

1‧‧‧輸送導管 1‧‧‧ delivery catheter

2‧‧‧抽吸漏斗導管、抽吸漏斗 2‧‧‧Aspirating funnel catheter, suction funnel

3‧‧‧經覆蓋之支架、經覆蓋之漏斗、支架漏斗、自膨式漏斗 3‧‧‧ Covered stent, covered funnel, stent funnel, self-expanding funnel

4‧‧‧漏斗覆蓋物 4‧‧‧Fountain Cover

5‧‧‧錐形擴張器導管 5‧‧‧Conical dilator catheter

6‧‧‧血管、動脈 6‧‧‧Vascular, arterial

7‧‧‧血栓 7‧‧‧thrombotic

12‧‧‧放射線不透性標記、放射線攝影標記 12‧‧‧radiation impermeable markers, radiographic markers

13‧‧‧放射線不透性標記、放射線攝影標記 13‧‧‧radiation impermeable markers, radiographic markers

Claims (32)

一種血栓清除裝置，其包含一輸送導管(1)、一錐形擴張器導管(5)、及一漏斗(3)，界定一遠端及一近端，該漏斗(3)可定位在一回縮位置及一伸長位置，其特徵在於該漏斗(3)亦包含一覆蓋物(4)，該漏斗(3)之遠端的直徑於伸長位置係比於回縮位置更大。 A thrombus removal device comprising a delivery catheter (1), a conical dilator catheter (5), and a funnel (3) defining a distal end and a proximal end, the funnel (3) being positionable once The retracted position and the extended position are characterized in that the funnel (3) also includes a covering (4) having a distal end having a larger diameter in the extended position than the retracted position. 如請求項1之血栓清除裝置，其中，該漏斗(3)包含一覆蓋物(4)。 A thrombus removal device according to claim 1, wherein the funnel (3) comprises a covering (4). 如請求項1或2之血栓清除裝置，其中，該覆蓋物(4)為一種可生物相容性材料或多於一種可生物相容性材料之組合製成的一不透性膜。 A thrombus removal device according to claim 1 or 2, wherein the covering (4) is an impermeable membrane made of a biocompatible material or a combination of more than one biocompatible material. 如請求項1至3中任一項之血栓清除裝置，其中，該覆蓋物(4)係由一種可生物相容性彈性體聚合物或多於一種可生物相容性彈性體聚合物之組合或其它塑性材料製成。 The thrombus removal device of any one of claims 1 to 3, wherein the covering (4) is a biocompatible elastomeric polymer or a combination of more than one biocompatible elastomeric polymer Or other plastic materials. 如請求項1至4中任一項之血栓清除裝置，其中，該覆蓋物(4)係從已膨脹的聚四氟乙烯(ePTFE)製成，有或無聚合物纖維平行於裝置之長度方向定向。 The thrombus removal device of any one of claims 1 to 4, wherein the covering (4) is made of expanded polytetrafluoroethylene (ePTFE) with or without polymer fibers parallel to the length of the device Orientation. 如請求項1至4中任一項之血栓清除裝置，其中，該覆蓋物(4)係自具有彈性體表現的可生物相容性聚胺基甲酸酯製成。 The thrombus removal device of any one of claims 1 to 4, wherein the covering (4) is made of a biocompatible polyurethane having an elastomeric expression. 如請求項1至4及6中任一項之血栓清除裝置，其中，該覆蓋物(4)係自具有允許該漏斗之重新護套的彈性體表現的可生物相容性聚胺基甲酸酯製成。 The thrombus removal device of any one of claims 1 to 4, wherein the covering (4) is a biocompatible polyurethane having an elastomer that allows recoating of the funnel. Made of ester. 如請求項1之血栓清除裝置，其中，該漏斗(3)係由金屬或金屬合金、聚合物、陶瓷或其組合製成。 The thrombus removal device of claim 1, wherein the funnel (3) is made of a metal or a metal alloy, a polymer, a ceramic, or a combination thereof. 如請求項1、2或8之血栓清除裝置，其中，該漏斗(3)係由形狀記憶材料製成。 A thrombus removal device according to claim 1, 2 or 8, wherein the funnel (3) is made of a shape memory material. 如請求項1或9之血栓清除裝置，其中，該漏斗(3)係由鎳鈦合金製成。 The thrombus removal device of claim 1 or 9, wherein the funnel (3) is made of a nickel titanium alloy. 如請求項1之血栓清除裝置，其中，該漏斗(3)係以機械構件膨脹。 The thrombus removal device of claim 1, wherein the funnel (3) is inflated with a mechanical member. 如請求項11之血栓清除裝置，其中，該機械構件為單一導管汽球或一集合之導管汽球。 The thrombus removal device of claim 11, wherein the mechanical member is a single catheter balloon or a collection of catheter balloons. 如請求項1之血栓清除裝置，其中，該漏斗(3)為自膨式。 The thrombus removal device of claim 1, wherein the funnel (3) is self-expanding. 如請求項1之血栓清除裝置，其中，該漏斗(3)能夠膨脹至約2毫米至15毫米之直徑。 The thrombus removal device of claim 1, wherein the funnel (3) is expandable to a diameter of about 2 mm to 15 mm. 如請求項1之血栓清除裝置，其係包含光滑的親水性或斥水性被覆層(8、9、10)。 A thrombus removal device according to claim 1, which comprises a smooth hydrophilic or water repellent coating layer (8, 9, 10). 如請求項1之血栓清除裝置，其中，該漏斗(3)包含光滑的親水性或斥水性被覆層(8)。 The thrombus removal device of claim 1, wherein the funnel (3) comprises a smooth hydrophilic or water repellent coating (8). 如請求項1之血栓清除裝置，其中，該輸送導管(1)包含光滑的親水性或斥水性被覆層(9)。 A thrombus removal device according to claim 1, wherein the delivery catheter (1) comprises a smooth hydrophilic or water repellent coating (9). 如請求項1之血栓清除裝置，其中，該擴張器導管(5)包含光滑的親水性或斥水性被覆層(10)。 A thrombus removal device according to claim 1, wherein the dilator catheter (5) comprises a smooth hydrophilic or water repellent coating (10). 如請求項1之血栓清除裝置，其進一步包含放射線不透性標記。 The thrombus removal device of claim 1, which further comprises a radiopaque marker. 如請求項19之血栓清除裝置，其中，該放射線不透性標記(13)係位在該漏斗(3)上。 The thrombus removal device of claim 19, wherein the radiopaque marker (13) is tethered to the funnel (3). 如請求項19之血栓清除裝置，其中，該放射線不透性標記(13)係位在該輸送導管(1)上。 The thrombus removal device of claim 19, wherein the radiopaque marker (13) is tethered to the delivery catheter (1). 如請求項19之血栓清除裝置，其中，該放射線不透性標記(13) 係位在該擴張器導管(5)上。 The thrombus removing device of claim 19, wherein the radiopaque marker (13) Fastened to the dilator catheter (5). 如請求項1之血栓清除裝置，其中，當該漏斗(3)的直徑膨脹時該漏斗(3)的長度縮短。 The thrombus removal device of claim 1, wherein the length of the funnel (3) is shortened as the diameter of the funnel (3) expands. 如請求項1之血栓清除裝置，其中，該漏斗包含用於保有血栓的保持構件。 The thrombus removal device of claim 1, wherein the funnel comprises a holding member for retaining a thrombus. 如請求項24之血栓清除裝置，其中，該保持構件為尖銳物理元件諸如棘刺、扦插、鋸齒、夾具或其任一項組合。 The thrombus removal device of claim 24, wherein the retaining member is a sharp physical element such as a spine, a cutting, a serration, a clamp, or a combination thereof. 如請求項1之血栓清除裝置，其中，該漏斗(3)及其相關導管(1、2、5)係沿相同軸定向。 The thrombus removal device of claim 1, wherein the funnel (3) and its associated conduit (1, 2, 5) are oriented along the same axis. 如請求項1之血栓清除裝置，其中，該裝置包含用於將該漏斗(3)再度導入該輸送導管(1)內的重新護套元件(11)。 A thrombus removal device according to claim 1, wherein the device comprises a re-sheathing element (11) for reintroducing the funnel (3) into the delivery catheter (1). 如請求項27之血栓清除裝置，其中，該重新護套元件為套管(11)、夾具、漏斗或其任一項組合。 The thrombus removal device of claim 27, wherein the resheathing element is a cannula (11), a clamp, a funnel, or a combination thereof. 如請求項1之血栓清除裝置，其中，該漏斗(3)於回縮位置係定位在該擴張器導管(5)的內部及於膨脹位置係定位在該擴張器導管(5)的至少部分外部。 The thrombus removal device of claim 1, wherein the funnel (3) is positioned inside the dilator catheter (5) in a retracted position and is positioned at least outside of the dilator catheter (5) in an expanded position. . 一種用於自血管抽取血管栓塞之系統，其包含前述請求項中任一項之一血栓清除裝置、一通訊通道、一控制模組、一作用系統、一資料儲存裝置、及一導引系統。 A system for withdrawing a blood vessel from a blood vessel, comprising a thrombus removal device, a communication channel, a control module, an action system, a data storage device, and a guidance system. 如請求項30之系統，其進一步包含一成像裝置、一第一放射線標記、及一第二放射線標記，其中該第一放射線標記指示漏斗的遠端之位置，及該第二放射線標記指示血管栓塞之位置。 The system of claim 30, further comprising an imaging device, a first radiation marker, and a second radiation marker, wherein the first radiation marker indicates a position of a distal end of the funnel, and the second radiation marker indicates a blood vessel embolization The location. 如請求項30之系統，其進一步包含一電腦輔助控制器。 The system of claim 30, further comprising a computer-aided controller.
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